BEUDAMED
    FDA Adverse Event Other Summary report: N

    B50 ULTRASAFE INJECTION SYSTEM NEEDLEGUARD

    MDR report key: 353225 · Received September 22, 2001

    Report

    Report Number
    2029163-2001-00001
    Event Type
    Other
    Date Received
    September 22, 2001
    Report Date
    September 22, 2001
    Manufacturer
    UNK
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTED TO THE DISTRIBUTOR THAT A NEEDLE STICK INCIDENT HAD OCCURRED WITH THE NURSING STAFF. THE NURSE WHO RECEIVED THE NEEDLE STICK PROVIDED THE FOLLOWING INFO: THE INCIDENT HAD NOTHING TO DO WITH THE NEELDE GUARD AND THAT SHE RECEIVED A NEEDLE STICK WHILE REMOVING THE NEEDLE COVER, PRIOR TO INJECTION INTO THE PT. THIS INFO INDICATES THAT THIS WAS NOT AN ADVERSE EVENT. IT IS UNKNOWN TO SAFETY SYRINGES, INC., WHETHER THE NURSE INVOLVED WITH THIS EVENT RECEIVED ANY MEDICAL TREATMENT OTHER THAN FIRST AID.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED A NEEDLE-STICK TO ONE OF THEIR HEALTHCARE PROFESSIONALS, WHILE USING THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT. THE INVESTIGATION IS ONGOING AND A SUPPLEMENTAL REPORT WILL FOLLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43206 B50 ULTRASAFE INJECTION SYSTEM NEEDLEGUARD NEEDLE FMF UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other